Z-1421-2013Class II

Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and...

Name: Z-1421-2013 Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and...
Creator: Alphatec Spine, Inc.
Published: 2013-05-06
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2013-05-06 / Terminated / root cause: design

FDA source

Alphatec Spine, Inc. began a recall of Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments on 2013-05-06. FDA classified it as Class II and gives the reason as "Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1421-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-05-28
Terminated: 2014-09-25
Recalling firm: Alphatec Spine, Inc.
Product: Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
Root cause tag: design
FDA root cause: Device Design
Action: Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 1,814
Distribution: Nationwide Distribution.
Product codes and lots: 83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1421-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1421-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-28

Product code NKB

K113366Class IILeucadia Autolok Pedicle Screw SystemPhygen, LLC / cleared 2012-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)